A Novel Classification of Sagittal Spinal Alignment to Aid Surgical Planning for Adult Spinal Deformity

NCT ID: NCT06470152

Last Updated: 2024-06-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2027-12-01

Brief Summary

Surgical outcomes, including radiographic outcomes, patient-reported outcomes, postoperative complications, and revision surgery rates, were compared in patients with adult spinal deformity who underwent correction surgery with reference to our pelvic incidence-dependent (PI-dependent) clustering of sagittal spinal alignment and existing standards (sagittal age-adjusted score [SAAS], global alignment and proportion [GAP] score, and Roussouly classification). Our findings may provide tangible guidance for surgical decision-making in ASD.

Conditions

Adult Spinal Deformity; Sagittal Deformity; Sagittal Alignment; Sagittal Imbalance

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Patients with ASD undergoing correction surgery in reference to our novel criteria

Correcting deformity according to the PI-dependent clustering of sagittal spinal alignment.

Group Type: EXPERIMENTAL

Correction strategy in reference to our PI-dependent clustering of sagittal alignment

Intervention Type: PROCEDURE

For type I patients (PI \< 39.56°), the target LL = -0.13\*PI2+9.36\*PI-134.08; for type II patients (39.56° ≤ PI \< 49.16°), the target LL = 0.45\*PI+26.57; for type III patients (49.16° ≤ PI \< 58.31°), the target LL = -0.15\*PI2+17.09\*PI-420.57; for type IV patients (PI \> 58.31°), the target LL = 0.06\*PI2-7.55\*PI+289.77. Prediction intervals of 95% confidence is adopted as the target LL range.

Patients with ASD undergoing correction surgery in reference to SAAS score.

Correcting deformity according to the SAAS score.

Group Type: OTHER

Correction strategy in reference to the SAAS score

Intervention Type: PROCEDURE

This new score is composed of three sagittal parameters (PI-LL, PT and TPA). For these three parameters, points were assigned based on offset with age-adjusted targets 0 points if the parameter was within 10 years of the patient's age (Match). For each 20 years above the age-adjusted target, 1 point was added (e.g., + 1 point between + 10 and + 30, + 2 points between +30 and +50). Conversely, 1 point was subtracted for each 20 years below the age-adjusted target (e.g., -1 point between -10 and -30, -2 points between -30 and -50). SAAS was calculated by adding all 3 components, creating a discreet score that could have a negative value (under corrected) or positive value (over corrected). SAAS was sub-categorized into "SAAS-Under" if it was less than -1, "SAAS-Match" if it was between -1 and + 1 or "SAAS-Over" if it was greater than + 1.

Interventions

Correction strategy in reference to our PI-dependent clustering of sagittal alignment

For type I patients (PI \< 39.56°), the target LL = -0.13\*PI2+9.36\*PI-134.08; for type II patients (39.56° ≤ PI \< 49.16°), the target LL = 0.45\*PI+26.57; for type III patients (49.16° ≤ PI \< 58.31°), the target LL = -0.15\*PI2+17.09\*PI-420.57; for type IV patients (PI \> 58.31°), the target LL = 0.06\*PI2-7.55\*PI+289.77. Prediction intervals of 95% confidence is adopted as the target LL range.

Intervention Type: PROCEDURE

Correction strategy in reference to the SAAS score

This new score is composed of three sagittal parameters (PI-LL, PT and TPA). For these three parameters, points were assigned based on offset with age-adjusted targets 0 points if the parameter was within 10 years of the patient's age (Match). For each 20 years above the age-adjusted target, 1 point was added (e.g., + 1 point between + 10 and + 30, + 2 points between +30 and +50). Conversely, 1 point was subtracted for each 20 years below the age-adjusted target (e.g., -1 point between -10 and -30, -2 points between -30 and -50). SAAS was calculated by adding all 3 components, creating a discreet score that could have a negative value (under corrected) or positive value (over corrected). SAAS was sub-categorized into "SAAS-Under" if it was less than -1, "SAAS-Match" if it was between -1 and + 1 or "SAAS-Over" if it was greater than + 1.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. ≥ 18 years of age at the time of treatment;

2. Complete radiographic data, including standing posteroanterior and lateral whole-spine radiographs, lumbar computed tomography, and lumbar magnetic resonance imaging;

3. Radiographic evidence of ASD: sagittal vertical axis ≥ 50 mm, pelvic tilt ≥ 25°, pelvic incidence-lumbar lordosis mismatch ≥ 10°, and/or thoracic kyphosis ≥ 60°.

Exclusion Criteria

1. Any type of previous spinal surgery;

2. Other musculoskeletal problems impeding walking ability, syndromic or neuromuscular diseases such as Parkinson&#39;s disease, inflammatory conditions such as ankylosing spondylitis, infectious conditions such as spinal tuberculosis, metabolic diseases such as severe osteoporosis, and/or serious general medical conditions such as sepsis or malignancy;

3. Pathology of deformity as follows: post-traumatic deformity, adult idiopathic scoliosis of the thoracic spine, or de-novo lumbar scoliosis;

4. Hip joint Kellgren-Lawrence grade ≥ II, history of hip joint and/or knee joint pain, and/or previous joint replacement.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Shibao Lu, M.D.

Role: CONTACT

wdfdoctor@126.com

18810728213

Dongfan Wang, M.D.

Role: CONTACT

1026607981@qq.com

13821337116

Facility Contacts

Dongfan Wang

Role: primary

wdfdoctor@126.com

13821337116

Other Identifiers

xuanwu_ASD

Identifier Type: -

Identifier Source: org_study_id